MalfunctionFMC
NS-3600-B LITE GLOVE 1000/CASE
Received Nov 29, 2016 · Event occurred Oct 26, 2016
Report 9612030-2016-00742 · MDR key 6131518
Device
Product problems
- Torn Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 11/29/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT AN ISSUE OCCURRED WITH A LITE GLOVE. CUSTOMER STATES THEIR LIGHT HANDLE COVERS (2EA) TORE/SPLIT WHEN THEY WENT TO USE THEM. NO REPORTED INJURY OR DEATH.